Vaginal speculum apparatus

ABSTRACT

A vaginal speculum apparatus includes a portable illumination assembly that is releasably attached to one of the upper blade and lower blade of a disposable vaginal speculum. The portable illumination assembly is defined by a housing that retains at least one LED and a portable power supply. The portable illumination assembly can be energized by an externally accessible member after the illuminator has been attached to the speculum.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation patent of U.S. Ser. No. 15/453,436filed on Mar. 8, 2017, which is a continuation of U.S. Ser. No.15/149,747 filed on May 9, 2016, which is a continuation of U.S. Ser.No. 14/169,850 (now U.S. Pat. No. 9,332,898), issued May 10, 2016, whichis a continuation of U.S. Ser. No. 11/910,387 (now U.S. Pat. No.8,821,395), issued on Sep. 2, 2014, which is a national stageapplication of PCT/US2006/012116, filed on Apr. 3, 2006. The prior PCTapplication is further based upon the following two (2) provisionalpatent applications, claiming priority based on 35 USC § 119(e): U.S.Ser. No. 60/667,505, filed Apr. 1, 2005, entitled: ILLUMINATED VAGINALSPECULUM ASSEMBLY; and U.S. Ser. No. 60/735,576, filed Nov. 10, 2005,entitled: ILLUMINATED VAGINAL SPECULUM ASSEMBLY. The entire contents ofeach above-noted application is herein incorporated by reference intheir entirety.

FIELD OF THE DISCLOSURE

This application generally relates to the field of hand-held medicaldiagnostic instruments, and more particularly to a vaginal speculumapparatus including a single-use or single patient speculum thatdistributes illumination from at least one illumination assemblyattached to the speculum.

BACKGROUND OF THE DISCLOSURE

Vaginal specula are commonly known apparatus presently used in the fieldof diagnostic medicine for purposes of examining the cervix of a femalepatient. A typical vaginal speculum includes an upper blade member and alower blade member that are operated upon to open and close by means ofan articulation mechanism in order to dilate the vaginal cavity of thepatient. According to one version of a vaginal speculum apparatus thatis manufactured and sold by Welch Allyn, Inc. of Skaneateles Falls,N.Y., a corded illumination assembly is received within a hollow handleportion of a disposable speculum made from a molded plastic material.The illumination assembly includes a miniature light source, such as ahalogen or other miniature incandescent lamp, which is contained withinan assembly housing and is tethered by cabling to a dedicated (e.g., AC)power source. The light source is coupled, when received by the hollowhandle portion, with the proximal end of a curved light pipe disposedwithin the lower blade member, the light pipe being formed from a lighttransmissive material. Light is transmitted from the light source bymeans of internal reflection along the light pipe to a distal end, thelight pipe extending along the interior of the lower blade member. Lightis projected from the distal end of the light pipe toward the distal endof the lower blade member to the target (i.e., the cervix), therebypermitting a practitioner to conduct an effective patient examination.

One problem with the herein-described light pipe is that a so-called“hot” spot is developed at the distal light emitting end. The distallight emitting end further produces back reflection of light to the eyeof the user along a viewing aperture of the speculum that is formedbetween the upper and lower blade members at the proximal ends thereof.This back reflection produces considerable amounts of glare, therebyimpairing the effectiveness of an examination. In addition, theconfiguration of the distal end of the current light pipe providesnon-uniform light distribution at the target (e.g., the cervix).

Another problem is that the body of the light pipe extends into thelower field of view of the user (e.g., the physician), creatingobstruction of the target. In addition, shadowing of externalillumination is caused by the distal light pipe end.

A further concern is the amount of plastic material that is used in thelower blade member of the molded disposable speculum, including thematerial taken up by the light pipe and the hollow handle portion.Excessive plastic material results in extra cost of manufacture. Themolding of the lower blade member is further affected in that a stressconcentration is created at the distal end of the light pipe, based onits squared discontinuous end, resulting in weak location and potentialbreakage. Moreover, there is difficulty in molding due to the abruptchange in cross section near the gate.

Yet another problem is that body fluids expelled from examination areoften trapped by the distal end of the light pipe, producing acontamination issue as well as impairing the efficiency of examinationgiven the effect on light transmission of a buildup of fluids againstthe light-emitting surface of the light pipe.

Yet another problem is that the industry has become content with theconcept of utilizing a tethered illumination assembly. Though effectiveand highly useful, there are occasions in which such assemblies makeexamination impractical to perform such as, for example, instances inwhich the patient is bed-ridden. In these situations, the corded portionof the speculum apparatus can become an impediment to examining apatient. In addition, the use of corded illumination assemblies requiresa non-portable (e.g., AC) power supply to be present in the examinationarea, making field examinations difficult. Still further, cordedassemblies can become tangled or become a source of dirt or othercontamination, requiring frequent cleaning between examinations.

Yet still further, the advent of alternative light sources, such asLEDs, provide a means for providing efficient illumination with a longerservice life than that of incandescent lamps. Heretofore, theincorporation of such light sources in portable illumination systems forvaginal specula has been discouraged in the field due to inefficienciesin power conversion and illumination output. Provision of these lightsources, at least in certain instances is desirable, but presentlyunavailable for use in such apparatus.

SUMMARY OF THE DISCLOSURE

According to one aspect of the present application, there is provided avaginal speculum apparatus, said apparatus comprising a portableillumination assembly defined by a housing that retains a portable powersupply and at least one LED, and a speculum comprising an upper bladeand a lower blade, said lower blade including a handle portion sized toreceive at least a portion of said portable illumination assembly andwherein the at least one LED contained within said housing is coupled toa light pipe extending into the lower blade of the speculum.

The portable illumination assembly can be releasably attached to thespeculum. According to one version, the illumination assembly can beattached to the lower blade of the speculum and positioned therein so asto be optically coupled to the light pipe.

According to at least one version, the portable illumination assemblycan include means for energizing the at least one LED contained withinthe housing.

The LED energizing means can be disposed on the exterior of the housingof the portable illumination assembly. According to one version, aswitch mechanism can include a mechanical switch member, having aportion that is provided on the exterior of the housing, in which theswitch member is biased in an off position. Engagement of theillumination assembly with the receiving cavity of the speculum causes afeature within the speculum to act upon the biased switch member. Thefeature can include at least one protrusion, rib, or groove, forexample, that is formed within the receiving cavity. For example andaccording to a preferred version, a set of rails is provided to retainthe assembly and to permit automatic energization of the contained lightsource.

According to another version, the speculum can include at least oneopening that permits access to the LED energizing means of the portableillumination assembly.

At least one of the illumination assemblies can be powered by at leastone battery, either retained directly within an assembly housing oralternatively by way of a connected component, such as by means of anattached power adapter. The power adapter can be tethered to the housingor alternatively can include a body that is mechanically andelectrically linked or engaged with the housing. The power adapter cancontain either a primary or auxiliary power supply, depending on theapplication. For example, one power adapter provides auxiliary power inthe event that battery power is low or depleted. The auxiliary powersupply in this power adapter can be at least one battery or anon-compact (e.g., AC) power supply.

In a preferred version, the at least one battery is rechargeable whereinan illumination assembly containing same can be placed in a docking orrecharging station. The illumination assembly can include a low-batterypower indicator to notify the user that recharging may be necessary. Thedocking station can permit, according to one version, simultaneousrecharging of a plurality of illumination assemblies. In another versionand as noted, the illumination assembly can be separately attached to abackup or auxiliary power supply, such as an AC power supply or at leastone other battery.

In at least one version, the light pipe is releasably attached to thespeculum. In another version, the light pipe can be integral to thelower blade of the speculum.

In one version, the speculum is disposable and the portable illuminationassembly is reusable. Alternatively, the entire apparatus can bedisposable.

According to another aspect claimed herein, there is described a vaginalspeculum apparatus, said apparatus comprising a portable illuminationassembly comprising a portable power source and at least one LEDcontained within a common housing, and a speculum having an upper blade,a lower blade and a mechanism enabling relative movement between saidupper and lower blades to enable dilation of a patient, said portableillumination assembly being releasably attachable to one of said upperand said lower blades of said speculum.

In one version, the portable illumination assembly is axially receivedwithin a portion of the lower blade of the speculum. The illuminationassembly can be coupled to a proximal end of a light pipe, the lightpipe having a distal light emitting end. The portable illuminationassembly can be releasably or otherwise coupled to the light pipe. Inone version, the speculum includes a cavity disposed in a handle portionof the lower blade, the cavity being configured to receive at least aportion of the illumination assembly housing.

According to one version, the portable illumination assembly housingincludes externally accessible means for energizing the at least oneLED. For example, the illumination assembly can include a switchmechanism to energize the contained light source automatically whenplaced at least a predetermined distance into the receiving cavity.Additionally, removal of the illumination assembly, according to thisversion, automatically causes the light source contained therein to bede-energized.

In one version, the LED energizing means can include an exterior switchmember that is acted upon by a corresponding feature of the speculum tocause automatic energization/de-energization of the contained lightsource. For example, the speculum can include at least one protrusion,tab, groove or other suitable engagement feature for acting upon theexterior switch member or can act upon a close contacting fit with theinterior of the receiving cavity.

In another version, the LED energizing means is configured for manualoperation, thereby enabling the illumination assembly to also act as anexamination light without the speculum, as needed. The speculum caninclude at least one feature, such as at least one opening, enablinguser access to the LED energizing means, even while the illuminationassembly is inserted within the speculum, enabling the illuminationassembly to be selectively de-energized without requiring removal.According to one version, the switch member is biased in an Offposition. The switch member can be manually located into a “locked”position with the contained light source being initially energized priorto insertion into the receiving cavity of the light source. In the“locked” position, the automatic energization features of thespeculum/assembly would not be active and the bias feature is overriddenuntil the user moves the switch member out of this “locked” position.

The illumination assembly can be retained by at least oneengagement/retention feature provided within the receiving cavity, suchas grooves, channels, ribs and the like, wherein the at least oneengagement/retention feature can also co-act to permit specificalignment of the illumination assembly relative to the receiving cavity.

According to one version, the illumination assembly can utilize thealignment/retention features, but the assembly can be disposed in one ormore rotational orientations within the receiving cavity about a primaryaxis of the illumination assembly, while also permitting automaticoperation of the switch mechanism.

According to one version, the speculum is disposable, Alternatively, theentire apparatus, including the illumination assembly, is disposable.

According to yet another aspect claimed herein, there is provided amethod of assembling a vaginal speculum apparatus, said apparatuscomprising a vaginal speculum having upper and lower blades, said methodcomprising the steps of releasably attaching a portable illuminationassembly to one of said upper blade and said lower blade and configuringsaid illumination assembly with exterior accessible means to enableenergization of a contained LED. The illumination assembly can betethered or otherwise connected to a dedicated (e.g., AC) power supplyor can include means for receiving at least one battery for powering theat least one LED, such as a white LED.

The illumination assembly includes a power supply and a mechanism forselectively energizing the at least one contained LED, eitherautomatically upon attachment to the speculum, and/or manually by theuser. At least one opening can be provided in the speculum to enable auser to access the exterior accessible means for energizing thecontained LED.

According to one version, a receiving cavity of the speculum includesfeatures to permit the illumination assembly to be retained by thespeculum, such as ribs, protrusions or grooves. The retaining featurescan also serve to align the illumination assembly with respect to thereceiving cavity and with features that would enable automaticenergization/de-energization of the at least one LED.

The apparatus can include means for dissipating heat generated by theillumination assembly. In one instance, the handle portion is sized tochannel heat from the illumination assembly. In another instance, atleast one air gap is formed in the receiving cavity.

In one version, the illumination assembly can be coupled with a lightpipe upon attachment of the illumination assembly to the speculum. Thelight pipe can be releasably attached to the speculum or integraltherewith. In one version, the speculum is disposable. In an alternativeversion, the entire apparatus is disposable.

In addition, the portable illumination assembly can be attached withoutmodification to the speculum.

The speculum apparatus further permits existing illumination assembliesto be adaptively attached to the handle portion of a speculum.

These and other objects, features and advantages will be readilyapparent from the following Detailed Description which should be read inconjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a vaginal speculum apparatus made inaccordance with the prior art;

FIG. 2 is a front perspective view of a prior art disposable vaginalspeculum used in the apparatus of FIG. 1;

FIG. 3 is a rear view of the prior art disposable vaginal speculum ofFIG. 2;

FIG. 4 is a front perspective view of the prior art disposable vaginalspeculum of FIGS. 2-3;

FIG. 5 is a partially unassembled rear perspective view of a vaginalspeculum apparatus that is made in accordance with a first embodiment;

FIG. 6 is a rear perspective view of the vaginal speculum apparatus ofFIG. 5, as assembled;

FIG. 7 is a front perspective view, partially unassembled, of thevaginal speculum apparatus of FIGS. 5 and 6;

FIG. 7A is a perspective view of a disposable sheath member used tocover a portion of the illumination assembly of the vaginal speculumapparatus of FIG. 7;

FIG. 8 is a side perspective view of an illumination assembly used inthe vaginal speculum apparatus of FIGS. 5-7;

FIG. 9 is a bottom view, taken in perspective, of the vaginal speculumof the apparatus depicted in FIGS. 5-7;

FIG. 10 depicts a partial bottom end view of the vaginal speculum ofFIGS. 5-7;

FIG. 11 is a bottom perspective view of the illumination assembly ofFIG. 8;

FIG. 12 is a perspective view of the illumination assembly of FIGS. 8and 11, with the cover removed;

FIG. 13A depicts the interchangeability of a corded illuminationassembly relative to the vaginal speculum of FIGS. 5-7;

FIG. 13B depicts an enlarged view of a portion of the apparatus depictedin FIG. 13A;

FIG. 14 is a bottom perspective view of an alternative vaginal speculumdesign;

FIG. 15 is a perspective view of a vaginal speculum apparatus includinga cordless illumination assembly made in accordance with anotherembodiment;

FIG. 16 depicts the vaginal speculum apparatus according to FIG. 15,including a docking station;

FIG. 17 is a perspective view of a corded illumination assembly made inaccordance with another embodiment;

FIG. 18 is an exploded view of a vaginal speculum apparatus inaccordance with another embodiment;

FIG. 19 is an exploded view of a light cartridge used in theillumination assembly of the vaginal speculum apparatus of FIG. 18;

FIG. 20 is a rear perspective view of the vaginal speculum apparatus ofFIG. 18 in an assembled condition;

FIG. 21 is a side view of the disposable speculum and an illuminationassembly of FIGS. 18-20 in an unassembled condition;

FIG. 22 is a functional electrical block diagram of the illuminationassembly of FIGS. 11 and 12;

FIG. 23 is a side view of a vaginal speculum apparatus made inaccordance with another embodiment, similar to that of FIGS. 16 and 17;

FIG. 24 is a side view of a vaginal speculum apparatus made inaccordance with another embodiment;

FIG. 25 is a perspective view of the distal end of the light pipe of thevaginal speculum that is depicted in FIGS. 5-7;

FIG. 26 is an enlarged view of a section of the bottom blade member ofthe vaginal speculum depicted in FIGS. 5-7;

FIG. 27 is a side cross sectional view of the light pipe of the vaginalspeculum of FIGS. 5-7;

FIG. 28 is a partially unassembled view of a vaginal speculum apparatusmanufactured in accordance with another embodiment;

FIG. 29 is a top perspective view of an illumination assembly used inthe vaginal speculum assembly of FIG. 28;

FIG. 30 is a side view of the vaginal speculum apparatus of FIGS. 28 and29, shown in one assembled condition;

FIG. 31 is a rear perspective view of the vaginal speculum apparatus ofFIGS. 28 and 29, shown in an alternative assembled position;

FIGS. 32 and 33 are perspective views of a speculum adapter as used witha corded illumination assembly in an unassembled and partially assembledcondition; FIG. 34 is a diagrammatic view of alternative versions ofpower adapters used with the vaginal speculum apparatus of FIGS. 5-7;

FIG. 35 is a side perspective view of a vaginal speculum apparatus madein accordance with another exemplary embodiment;

FIG. 36 is a side view representing a vaginal speculum apparatus made inaccordance with another exemplary embodiment; and

FIG. 37 is a bottom perspective view of a portion of the vaginalspeculum apparatus of FIG. 36, in particular representing the top bladeof a disposable speculum having an illuminator assembly releasablyattached thereto.

DETAILED DESCRIPTION

The following relates to an illuminated vaginal speculum apparatus aswell as certain aspects of the apparatus that are herein described andbased on various embodiments in accordance with this application. Itshould be readily apparent from the discussion that follows, however,that there are many variations and modifications that will be apparentto one of sufficient skill in the field, and that are intended to bewithin the scope of the inventive concepts. In addition, certain termsare used throughout the discussion, such as “top”, “upper”, “bottom”,“lower”, “above”, “below”, “proximal” and “distal”, each of which areprovided in order to provide a suitable frame of reference with regardto the accompanying drawings. These terms, however, are not intended tobe overlimiting, except where so specifically indicated.

Referring first to FIGS. 1-4, there is shown a prior art vaginalspeculum apparatus 100 that includes a disposable speculum 102 and areusable illumination assembly 140. The disposable speculum 102 includesthree (3) interconnected components; namely, a lower or bottom blademember 104, an upper or top blade member 108, and a slide member 112.Each of the two blade members 104, 108 is preferably made from a clear,durable plastic material, such as acrylic or polystyrene, wherein eachof the lower blade member 104 and upper blade member 108 include atrough-shaped distal blade 116. A handle portion 120 extends verticallydownward from the proximal or rear end of the lower blade member 104,wherein the handle portion is integrally molded as part of the lowerblade member.

An intermediate portion of the slide member 112 is fitted within a guideslot (not shown) that is provided on a rearward facing side of thehandle portion 120, the slide member further having a forked upper endor yoke 124 that receives the upper blade member 108, which is pivotallyattached thereto, including a downwardly extending lever portion 128extending from the proximal end of the blade member.

The lever portion 128 further includes an opening 135, shown only inFIG. 3, defining a user aperture between the yoke 124 and the lower andupper blade members 104, 108. The lever portion 128 terminates in a tab137, the latter having an interior slot 139. The interior slot 139 isengageable with a flexible rear extending projection 123 of the slidemember 112 provided beneath the yoke 124, and more particularly with aaxially disposed set of ratchet teeth 125 that are provided on a lowerfacing surface of the projection. The ratchet teeth 125 of the flexibleprojection 123 are biased into the interior slot 139 of the leverportion 128 of the upper blade member 108. Angular articulation betweenthe lower and upper blade members 104, 108 is initiated by applyingfinger pressure inwardly against the tab 137, causing the lever portion128 to move along the set of ratchet teeth 125, and providing positiveengagement therewith.

In addition, the slide member 112 further includes a lower tongue 129having a single ratchet tooth 130 that engages with a set ofcorresponding teeth 131 that are provided on the rear exterior side ofthe handle portion 120 in order to provide relative vertical adjustmentbetween the lower and upper blade members 104, 108, as needed.Additional details relating to the disposable speculum 100 depictedherein, including the adjustment of the upper and lower blade members104, 108, can be found in U.S. Pat. No. 3,716,047, the entire contentsof which are herein incorporated by reference.

Referring to FIG. 1, the handle portion 120 of the disposable speculum100 includes a receiving cavity 133 that is sized for receiving ahousing 144 of the reusable illumination assembly 140. The housing 144retains a miniature incandescent lamp, such as a halogen bulb, which issealingly retained within a distal portion 148 thereof. A proximalportion of the housing 144 extending from the receiving cavity 133, whenassembled to the speculum 100, includes a strain relief 152 extending toan electrical cable 156 that further extends to a switch assembly 160.As shown in FIG. 1, an electrical cable 164 extends from the switchassembly 160 to a pronged plug 168 that engages a corresponding femaleplug 172, the latter being tethered by a corresponding cable 174extending to a power supply transformer 176. The switch assembly 160 isdefined by an elastomeric housing, having a depressible button 163 thatis used to selectively energize the miniature incandescent lamp (notshown) contained within the distal portion 148 of the illuminatorhousing 144. Specific details relating to the illumination assembly 140can be found in commonly assigned and co-pending U.S. Patent ApplicationPublication No. 2004/0184288 A1, entitled: ILLUMINATION ASSEMBLY HAVINGFLUID-TIGHT SEAL, the entire contents of which are herein incorporatedby reference.

Referring to FIGS. 1-4, and in order to direct light from theillumination assembly 140 to the target of interest, a curved light tubeor pipe 146 is provided, the light pipe having a proximal end disposedin the upper end of the handle portion 120 of the lower blade member104, FIG. 2. When the housing 144 is inserted into the receiving cavity133 of the handle portion 120 of the speculum 100, the containedminiature incandescent lamp is optically coupled to the proximal end ofthe light pipe 146. Emitted light is then directed by means of internalreflection through the length of the light pipe 146 to a flat distallight-emitting end 147 wherein the light is then distributedsubstantially along a longitudinal axis of the lower blade member 104towards the target. The light pipe 146 is preferably molded directlyinto the lower blade member 104, wherein the proximal end of the pipe,as noted, is provided in the upper end of the receiving cavity 133 ofthe handle portion 120. In operation, light from the coupledincandescent lamp is collected by means of a plastic lens (not shown inthese figures, but one of which is depicted in FIG. 27) that is alsopreferably directly molded into the proximal end of the light pipe 146.The lens has an appropriate curvature to collect the light from the lampof the illumination assembly 140 and conduct same through thetransmissive light pipe 146.

Though the light pipe 146 provides a coupling means for directingillumination from the contained miniature incandescent lamp of theillumination assembly 140, there are a number of issues relating to theinstrument design of FIGS. 1-4. First, the design of the light pipe 146,as clearly shown in FIGS. 2 and 3, produces an obstruction for the userwhen viewed through the defined proximal opening 135 of the disposablespeculum 100. More particularly, the reflective nature of the light pipe146 produces glare from light that is reflected proximally towards theuser from the distal end 147 of the pipe, wherein losses in efficientlight transfer detract from illumination of the target. Additionalinefficiencies are created in that the light pipe 146 produces a shadowwhen external illumination is used. In addition the distal end 147 ofthe light pipe 146, being flat and perpendicular to the centerline ofthe light pipe, produces a fluid-collection region that also blockslight from the target. A distal end 147 of the light pipe 146 asprovided herein also produces difficulties in injection molding.

Referring to FIGS. 5-7, there is shown a vaginal speculum apparatus 200that is made in accordance with a first embodiment. The vaginal speculumapparatus 200 includes a disposable speculum 204 and a illuminationassembly 230 that is releasably attached to the handle portion 216 ofthe speculum. In this embodiment, the handle portion 216 is hollow,including an open bottom end extending into an otherwise enclosedreceiving cavity 217. The handle portion 216, including the receivingcavity 217, is defined by a substantially rectangular cross section, thesignificance of which is detailed below.

Like the preceding, the disposable speculum 204 according to thisembodiment is generally defined by an upper or top blade member 212, alower or bottom blade member 214 (which integrally includes the handleportion 216), and a slide member 220. Each of the upper blade member 212and lower blade member 214 are similarly constructed as described withregard to FIGS. 1-4, wherein each member is preferably formed from adurable clear plastic material, such as acrylic or polystyrene, and inwhich each blade member is further defined by a trough-shaped elongatesection or blade 215, FIG. 7. The upper blade member 212 furtherincludes a lever portion 224 extending downwardly at its proximal endthereof. The slide member 220, also preferably being made from a durableplastic material, though not necessarily clear, further includes aforked upper portion or yoke 228 that pivotally receives the upper blademember 212, as well as a flexible projection 225 that is disposedimmediately beneath the yoke 228 and that extends rearward; that is,away from the handle portion 216. The flexible projection 225 isupwardly curved in a convex configuration (as depicted in FIG. 5), andincludes a set of ratchet teeth 226 that are disposed along a bottomsurface thereof.

The lever portion 224 is defined by a frame-like structure that includesan opening 221, defining an aperture through which the user can examinethe patient through the upper and lower blade members 212, 214, as wellas a bottom tab 227. Finger pressure on the bottom tab 227 allows theuser to angularly articulate the speculum 200, in a manner similar tothat described previously. According to this embodiment, an intermediateportion of the slide member 220 is movably (axially) disposed within aguide slot 223 extending over the entirety of the length of the rearside of the handle portion 216. Finger pressure on the lower tongue 229of the slide member 220 permits engagement between a single toothprovided on the slide member 220 and a set of external teeth 222provided on the proximal or rear side of the handle portion 216 andenables selective vertical articulation (spacing) of the lower blademember 214 with respect to the upper blade member 212 through selectivemovement of the slide member 220 and yoke 228. The guide slot 223extends axially through the set of external teeth 222, improvingmoldability as opposed to the version shown in FIG. 1.

As described in greater detail below, the receiving cavity 217 of theherein described disposable speculum 204 is sized to interchangeably andreleasably accommodate at least two illumination assemblies. As will bedescribed in greater detail below, the illumination assemblies that canbe interchangeably accommodated by the speculum can vary based on atleast one structural and/or functional aspect, including size, type ofpower supply, and type of light source. In one variation, the receivingcavity 217 of the speculum 204 can interchangeably receive either acorded illumination assembly 140, FIG. 1, and similarly constructedassemblies utilizing a non-portable power supply (e.g., an AC powersupply) or a portable illumination assembly such as, for example, theexemplary assembly 230 more completely shown in FIGS. 8, 11 and 12.Details relating to this exemplary version are now provided.

For purposes of reference, the cordless or portable illuminationassembly 230 according to this embodiment is at least partially depictedin each of FIGS. 5-8, 11 and 12. In brief, this illumination assembly230 is defined by a housing 236 having a substantially hollow interiorthat is sized to retain a number of components, as described below.

More specifically, the housing 236 is defined by a lower base portion260 and a narrower extending upper portion 245. According to the presentembodiment, the two portions 245, 260 are integrally formed by moldingthe housing, the housing being made from a durable plastic material. Thenarrower extending upper portion 245 is sized to fit entirely within thereceiving cavity 217 of the handle portion 216 and includes a shorttubular open-ended extending portion 238 projecting from a top surface235 thereof.

The upper portion 245 of the housing 236, as more clearly shown in FIGS.8 and 11, also includes a set of parallel guide rails 249 (only one ofwhich is shown in each of FIGS. 8 and 11) disposed along opposite sidesof the housing that are used to align the assembly 230 with respect tothe receiving cavity 217 of the speculum 204, permitting the assembly tobe fitted within the cavity in two rotational orientations, 180 degreesspaced from one another, as described in greater detail below.

As noted, the substantially hollow interior of the housing 236 is sizedto retain a number of components. More specifically and referring toFIG. 12, the tubular open-ended projecting portion 238 includes a spacertube 241. A lens 259 is fitted to a distal end of the spacer tube 241.The lens 259, according to this embodiment, has a piano-convexconfiguration and is recessed within the tubular extending portion 238.This lens 259 is used to more efficiently direct illumination from acoupled light source to a light pipe 254, FIG. 27, described in greaterdetail in a later section.

An upper portion of the light source is also retained within the spacertube 241. According to this embodiment, the light source is a miniaturewhite LED 232, shown schematically in FIG. 22, such as a Model LXHL-PW01white LED manufactured by Lumileds, Inc. The LED 232 includes a domedtransparent envelope (not shown) at its upper end that is aligned withthe lens 259 to provide optical coupling therewith. Moreover, theinterior of the spacer tube 241 provides a surface that acts to directstray light emitted from the envelope of the LED 232 and directs thislight toward the lens 259. Alternatively, the light source can be aminiature incandescent lamp, such as, for example, a halogen bulb, arclamp, or other suitable form of light source. In addition and though asingle light source is depicted herein, multiple sources could bedisposed within the housing 236, such as, for example, an array of LEDshaving different colors (e.g., blue, green, white) to provide thecumulative effect of a “red” free filter.

A lower portion of the LED 232 is retained within a heat sink 244 madefrom a heat conductive material, such as, for example, aluminum, intowhich the lower end of the spacer tube 241 extends, as well as theextending electrical contact wires (not shown) from the LED 232. Theheat sink 244 extends substantially across the width of the extendingupper portion 245 of the housing 236, with the exception of a recessedportion 272 that accommodates an inner walled cavity 276.

Still referring to FIG. 12, the illumination assembly further retains atleast one battery 242, in this instance, a single rechargeable lithiumion battery, such as a Model UF 812248P JFH battery, manufactured bySanyo Corp, the battery being disposed in a compartment defined by apair of tabs 280 for retaining the lower end of the battery. The upperend of the battery 242 is retained, according to this embodiment,against a portion of an inner wall defining the inner walled cavity 276,the latter being defined to receive a spring loaded plunger 284 beneaththe heat sink 244, the plunger being aligned for movement in a directionthat is perpendicular to the primary axis of the illumination assembly230.

A printed circuit board 240 that includes components and circuitry forpowering the LED 232 is disposed within the base portion 260 of theassembly housing 236 according to this embodiment. The circuit board 240includes circuits for controlling the current required by the LED 232.According to this embodiment, the circuit board 240 includes abuck-boost constant current LED driver 251, such as a Model LTC3453EUF,used for this purpose. According to this embodiment, the circuit board240 is retained and aligned within the housing 236 using a set of guiderails 285, though other suitable retaining means can be used. A set ofcharging contacts 286 are disposed immediately beneath the circuit board240, each projecting through a bottom surface 287 of the housing 236.According to this embodiment, three (3) such contacts are provided, eachof the contacts being equally spaced from one another, the purposes ofwhich are detailed below. The wires extending from the lower portion ofthe LED 232 and extending through the heat sink are passed behind thebattery 242 to the circuit board 240 and are connected therewith in aconventional manner, while wires extend from the circuit board 240 tothe negative terminal of the battery 242.

According to one version as described below, the battery 242 isrechargeable wherein the housing 236 is sized and configured to permitrecharging by attachment to a docking station. Details relating to theattachment of a housing of an illumination assembly is described in asubsequent embodiment, but for purposes of this discussion and referringback to FIGS. 11 and 12, the charging contacts 286 are engaged when thebase portion 260 of the housing 236 is placed within a port of thedocking station, the port being configured to retain same. The contacts286 are engaged with the lower surface of the circuit board 240 topermit recharging of the contained battery 242, the latter beingelectrically connected to the circuit board. In the present instance,the three charging contacts 286 enable the housing 236 to be installedin at least two 180 degree-spaced orientations within a slot of thedocking station and still enable recharging, the contacts thereforebeing position insensitive. In a preferred version and with reference toFIG. 22, the circuit board 240 further includes a short circuit/overcurrent protection device 247 to prevent shorting and overcharging ofthe battery 242. According to this embodiment, a Model UCC3952PW-1manufactured by Texas Instruments, Inc. is used, though other suitabledevices can be substituted.

According to the present embodiment, the base portion 260 furtherincludes a pair of clamping recesses 289, FIG. 11, that are used inconjunction with the charging contacts 286 to allow a “clothespin”mechanism (not shown) to engage therewith for charging or for auxiliarypower, as needed.

It should be noted in passing that various other configurations could beused for auxiliary or for primary powering of the herein describedillumination assembly 230. For example, and as shown in FIG. 34, thehousing 236 can be configured alternatively to accommodate a plug-incord 291 to a non-portable (e.g., AC) power supply by means of atransformer 296 in lieu of charging the battery 242, or when the batteryis nearly or fully depleted as indicated by a low battery powerindicator 295 provided on the exterior of the housing 236. According tothis embodiment, the low-battery power indicator 295 is providedadjacent the top of the upper portion 245 of the housing 236, but couldbe otherwise disposed such as along the bottom surface 287, FIG. 12, forexample, the indicator being connected in a conventional manner to thecircuit board 240, as shown schematically in FIG. 22. Still further, itis not necessarily required that the battery 242, FIG. 12, be disposedwithin the housing 236 but could alternatively be disposed in a poweradapter. As also shown in FIG. 34, the at least one battery 242 could bealternatively and separately contained within a power adapter 298 thatis either tethered to the assembly housing 236, such as by means of acable 293 that can plugged into a receptacle 297 in the base portion 260or a power adapter 288 having a contained battery (not shown) that ismechanically engaged to the bottom surface 287, FIG. 12, of the baseportion 260, such as using a set of pins 299 for engaging the chargingcontacts 286.

Referring to FIGS. 12 and 22 and according to the present embodiment, aconductive strip member 290 extends along an interior side wall of thehousing 236, the strip member having a lower end 292 that is disposedadjacent to conductive contacts 243 of the circuit board 240. Theconductive strip member 290 extends into the upper extending portion 245to switch contacts 294 that are disposed on the interior side of amechanical slider switch 248, the switch being disposed on the exteriorof the housing 236, as shown most clearly in FIGS. 11 and 12. The switch248 is configured, according to this embodiment, to permit automaticoperation when the housing 236 is disposed at least a predetermineddistance into the receiving cavity 217 of the handle portion 216, suchas through engagement between an internal feature within the receivingcavity 217 and the exterior surface of the switch 248. In this instance,the spring-loaded plunger 284 is used in conjunction with the interiorwall of the receiving cavity 217 to assist in engagement and inretaining the illumination assembly 230 in the receiving cavity 217.

According to this embodiment, the exterior surface of the slider switch248 includes a pair of external projections 253, one on each of theupper and lower end of the slider switch to aid in manual operation ofthe assembly. According to this embodiment, engagement causes the switch248 to move downwardly against the bias of a coil spring (not shown),biasing the switch in an Off position, and causes the lower end 292 ofthe conductive strip member 290 to electrically contact the conductivecontacts 243 of the circuit board 240, thereby completing the circuitand causing the LED 232 to energize.

According to this embodiment, the illumination assembly 230 furtherpermits the slider switch 248 to manually be preset to a lockedposition, in which the LED 232 can be energized prior to installing theassembly 230 into the receiving cavity 217, FIG. 5, of the speculum 204,FIG. 5. In this configuration, the slider switch 248 remains in thelocked position based on the downward engagement of the switch 248 byfinger pressure against one of the external projections 253 that locatesa detent pin 261 attached to a leaf spring 263. Finger pressure of theswitch 248 enables de-energization of the LED 232, but no automaticoperation when the illumination assembly 230 is locked, irrespective ofthe position of the housing 236 within the receiving cavity 217, FIG. 5.

Otherwise and when not placed in the “locked” position, removal of thehousing 236 from the receiving cavity 217 causes the switch 248 to beautomatically de-energized (e.g., by sliding the switch 248 upward tothe original position, moving the lower end 292 of the conductive stripmember 290 out of contact with the circuit board 240) and therebyde-energizing the contained light source (e.g., LED) 232. It should benoted that other forms of switch assemblies, such as, but not limited tooptical switches, magnetic/reed switches, and other mechanical switches(such as an ON/OFF throw switch that can be enabled with the speculumwhen engaged therewith to automatically or manually energize andde-energize the contained LED) can be utilized.

The cordless, self-contained and compact nature of the herein describedillumination assembly 230 as well as the operation, including thelocking feature of the exterior slider switch 248 further enable theherein described assembly to be useful independently as an examinationlight. The positioning of the LED 232 within the spacer tube 241 as wellas the positioning of the collecting lens 259 permit illumination to bedirectly efficiently and uniformly emitted. The positioning of thecontained LED 232 within the illumination assembly 230 and particularlywithin the heat sink 244 further provides a safety feature in that theexposed end of the tubular portion 238 can be brought into substantialcontact with a patient without particular risk of injury. Morespecifically, because the coupled lens is interior to the tubularextending portion 238, the lens 259 cannot be readily contacted by apatient or user. The lens 259 is further isolated from shock loads ifthe illumination assembly 230 is dropped.

Referring to FIGS. 13A and 13B and as noted, the receiving cavity 217 ofthe herein described vaginal speculum 204 further permits the releasableattachment of a corded illumination assembly 140, as previously depictedand shown with regard to FIG. 1. As shown in FIG. 9, the receivingcavity 217 includes a pair of opposed interior rail-like portions 250that are formed between two substantially interior parallel sidewalls ofthe handle portion 216, the rail portions extending along substantiallythe length of the receiving cavity 217 that are used to support andalign the corded illumination assembly 140. The rail-like portions 250are also used to align with the guide rails 249, FIG. 8, of the cordlessillumination assembly 230, according to this embodiment in which theassembly can be mounted in at least two 180 degree spaced orientations.

The upper portion of either illumination assembly housing 236, 144,including the extending tubular open-ended portion 238 of the housing236 or the distal portion 148, FIG. 1, of the illumination housing 144,FIG. 1 is received in the receiving cavity 217. A pair of oppositelydisposed internal centering fingers 246 form a guide in order to centerthe distal portion 148, FIG. 1, of the corded illumination assembly 140,FIG. 1, within the receiving cavity 217 in either of the two 180 spacedorientations. Lateral spring-like protrusions 136, FIG. 1, disposed onthe exterior of the illumination housing 144, FIG. 1, initially guideand orient the illumination assembly 140, FIG. 1, within the receivingcavity 133, FIG. 1. The protrusions 136, FIG. 1, also provide a securingfunction through a friction fit with the interior of the receivingcavity 133, FIG. 1.

In either instance, the corded illumination assembly 140 and thecordless or portable illumination assembly 230 can be installed into thereceiving cavity 217 of the handle portion 216 in which the light sourcecontained in each assembly is effectively coupled with the proximal endof a light pipe 254, FIG. 27, to uniformly illuminate the target. In thepreviously described cordless illumination assembly 230, the light isdirected from the contained LED 232, in part using the reflectiveinterior surface of the spacer tube 241 to the lens 259 that collectsthe light and then directs this light to a collecting lens 262, FIG. 27,as described below.

As previously noted, the upper portion 245 of the housing 236 is sizedto fit entirely within the receiving cavity 217, wherein the handleportion 216 is defined by an aspect (width×depth) ratio of approximately2:1 that substantially matches that of the upper portion 245, therebydefining a substantially close-contacting fit. A range of 1.25:1 to 3:1is suitable to provide adequate stability and greater rigidity, whilepermitting effective hand held operation. The extending base portion 260of the illumination assembly 230 further defines an effective length orworking length, as measured from a point P, FIG. 6, to the bottom end ofthe base portion 260 of 5.50 inches, as shown in FIG. 6 by “A”. Forpurposes of this discussion, point P is representative of the mostproximal part of the speculum 204 typically in contact with a patientfor purposes of examination and is located on the exterior underside ofthe lower blade member 214 along the elongate blade portion 215, FIG. 7,thereof, this point as noted being representative. More particularly,the point P is substantially located in the vicinity of the distal endof the light pipe 254, FIG. 27. A preferred range for “A” lies betweenapproximately 3 inches to approximately 6 inches, according to thisembodiment. In addition, the substantially rectangular end of the baseportion 260 provides a stable base for the user as well as effectiverigidity, wherein the apparatus 200, FIG. 5, can easily be hand-held.

Referring to FIGS. 25-27, the herein described speculum 204 includes alight pipe 254 having a proximal end 255, which is coupled to the lightsource of any of the interchangeably attached illumination assemblies140 and 230. The proximal end 255 further includes a collecting lens262. Rather than merely molding the lens into the proximal end, as doneaccording to previous versions, the lens 262 according to thisembodiment is molded as an inset in relation to the proximal end bymeans of a pedestal section 264 centered within an annular gap 265formed between the set of internal centering fingers 246. The pedestalsection 264 is reinforced within the annular gap 265 by at least one web(not shown) to prevent sagging. The collecting lens 262 by virtue ofthis construction provides improved optical coupling with the lightsource of either illumination assembly 140, FIG. 1, 230, FIG. 7. Thisimproved optical coupling results from improved mechanical alignment ofthe illumination assembly with the lens 262, FIG. 27, and from moreeffective internal reflection at the cylindrical portion of the lightpipe 254 in the annular gap 265.

Unlike that of the prior art, the distal end 258 of the light pipe 254is also different than the version of FIG. 2. According to thisembodiment, the distal end 258 is preferably molded into the lower blademember 214 and has a contoured configuration. By “contoured”, it ismeant that the surface of the distal end 258 has a defined shape that isnot a 90 degree cut with respect to the axis of the light pipe 254.Therefore, it is intended that this term can cover both a range ofangled surfaces as well as curvi-linear surfaces, such as spherical,parabolic and the like. The contour at the distal end 258 is preferablyformed as a scallop, such as would be cut by means of an end mill orsimilar apparatus. Alternatively, the above modification can be placedinto the molding process for the lower blade member 214 of the speculum204, for example, if the speculum is being made from polystyrene,acrylic or similar materials. It will be readily apparent that theconcept should not be restricted to these materials, but should also beapplied to literally any light transmissive material.

The contour provided in the distal light emitting end 258 according tothis particular embodiment is essentially a scalloped cut producing aninwardly (i.e., concave) curved portion having a radius of approximately1.5 to 3.5 inches. The center of the radius is provided from a point Q,FIG. 27, that is approximately 2.6 inches as measured distally from therear side of the handle portion 210 and approximately 2.4 inches, asmeasured vertically from the top of the trough 215, FIG. 7, of the lowerblade member 214. These dimensions are shown in FIG. 27. It is notedthat both dimensions locating point Q can be varied by approximately+/−0.30 inches and still produce a desirable effect. The herein defineddistal end 258 can alternatively be formed using an angled cutapproximating that of the radiused scallop end described above.According to one version, a suitable angle of approximately 70 degrees,as measured clockwise from the proximal upper end of the cut withrespect to the perpendicular is provided, thereby creating a downwardlyextending face. The angle can vary from approximately 55 degrees toapproximately 80 degrees for purposes of providing improved illuminationspot quality while still reducing glare to the user. Illumination ispassed through the entirety of the distal face such that fluid buildupwill not significantly interfere with light transmission. Thisconfiguration further prevents glare from being reflected back to theuser through the opening of the speculum and the contour itself furtherassists the user by being far less intrusive with regard to the field ofview as seen through the opening. Alternatively and in lieu of providinga continuous contoured surface, the distal end 258 can be provided witha series of stepped surfaces (not shown).

In operation, the light emitted from the coupled illumination assembly140, 230 is collected by the lens 262, FIG. 27, as positioned on thepedestal section 264, is reflected internally within the light pipe 254and then is emitted from the distal end 258. The emission of the lightis such that the light is directed towards the distal end of theelongate blade portion 215, FIG. 7, wherein significant light is notreflected back to the user viewing through the aperture or opening 221,FIG. 5.

In addition to the preceding, surfaces proximal to the light pipe 254 ofthe upper and lower blade members 212, 214 can be treated (e.g., as byfrosting). Such treatment assists in reducing unwanted light (that is,light other than that received from the target) from being directedtoward the user when the speculum 204 is used with an external lightsource. Similarly, the distal end 258 of the light pipe 254 can beprovided with a variety of different optical surfaces through treatmentthereof to smooth light output and control the distribution ofillumination.

FIG. 14 depicts an alternative design in which the receiving cavity 217Aof a disposable speculum can be modified to accommodate a cordlessillumination assembly (not shown) having a housing (not shown) that isconfigured to two AAAA batteries in side by side fashion. According tothis version, a set of rails 250A are sized to separately accommodatethe corded illumination housing, wherein the rails align the assembly aswell as retain the assembly in the receiving cavity 217A. In thisversion as well as the preceding embodiment, the handle portion 216,FIG. 5, 216A, FIG. 14, can further include a series of parallelvertically arranged ribs 256, FIG. 7, disposed on a front facing sidethereof, the ribs providing a means for dissipating heat developed bythe retained illumination assembly, as well as providing a means forkeeping a user's fingers away from “hot” surfaces. It has beendetermined that the provision of four (4) vertically extending exteriorribs 256, each having a depth of about 0.160 inches, a thickness ofabout 0.055 inches and having an equal spacing of about 0.150 inchesprovides additional protection. Other shapes can also be utilized.

At least one air gap is also developed, FIG. 13, in the receiving cavity217 based on the size differential between the receiving cavity and thecorded illumination assembly 140, the at least one air gap being used tochannel heat away from the illumination assembly 140 or an alternativeillumination assembly 140A, shown in FIG. 17 and described in greaterdetail below, that can include an LED as a light source in lieu of anincandescent lamp. Other means for dissipating heat can be utilized. Forexample, the housing 236 could at least partially contain a phase-changematerial (PCM), such as, for example, those manufactured by TEAP Energyin which residual heat developed or generated by the assembly isessentially stored during use and then later dissipated after use of theapparatus some later time after the illumination assembly has beendeactivated.

In addition to the preceding and referring to FIGS. 32 and 33, aspeculum adapter 281 can be used to facilitate attachment of a cordedillumination assembly 140B, to the receiving cavity 217 of the speculum204. The speculum adapter 281 according to the embodiment is aplastic-molded body that includes an external envelope 282 that isshaped essentially like that of housing 236. The speculum adapter 281further includes an internal envelope 283 that is adapted in thisinstance to accommodate the housing 144B of a corded illuminationassembly 140B containing a light source, such as an incandescent lamp orat least one LED (not shown). The speculum adapter 281 assumes afriction or snap fit or other substantial close contact with theinterior of the receiving cavity 217. The internal envelope 283 of theadapter 281 retains the illumination assembly 140B without requiringpredetermined alignment and enables optical coupling with the proximalend of the light pipe 254, FIG. 27. In operation, the speculum adapter281 is disposed in one of two 180 degree orientations within thereceiving cavity (not shown in this view) and the illumination assembly140B is fitted into the internal envelope 283, either prior to placingthe adapter 281 into the receiving cavity or afterward. The adapter 281is sized such that the distal portion 148B of the assembly extendstherethrough following assembly, allowing the contained light source tobe optically coupled with the light pipe (not shown in this view). Theadapter body provides a means for dissipating heat developed by thecontained illumination assembly wherein at least a portion of theadapter 281 could also further be made from a phase change material(PCM), such as those previously noted.

Due to the portable and non-tethered (cordless) nature of theillumination assembly 230, FIG. 7, according to this and other describedembodiments that follow, the herein described speculum apparatus 200 ismore versatile and can be used, for example, with bed-ridden patientsbased in part on the fact that there is no corded portion extending fromthe handle portion 216, 216A. As previously noted, the herein describedillumination apparatus has an effective working distance A, FIG. 6, ofapproximately 3 to 6 inches that provides increased versatility andutility with regard to patients on a bed or examination table. As such,there are no issues such as those that are previously encountered withcabled or tethered assemblies. Either illumination assembly 140, 230 canbe easily reused by removing same from the receiving cavity 217, 217A ofthe handle portion 216, 216A after an examination and discarding thespeculum 204. Alternatively, the corded illumination assembly 140, FIG.1, can be covered prior to use with a disposable sheath. An exemplaryversion of such a sheath is described in U.S. Patent ApplicationPublication No. 2004/0186355 A1, entitled: PROTECTIVE SHEATH FORILLUMINATION ASSEMBLY OF A DISPOSABLE VAGINAL SPECULUM, the entirecontents of which are herein incorporated by reference. A portion of anexemplary sheath assembly 1624 for this purpose is also depicted in FIG.23 utilizing a prior art speculum 102 that includes a slot 134, FIG. 1,formed adjacent the receiving cavity 133 at the bottom end of the handleportion 120, the slot being sized to accommodate the disposable sheathassembly 1624. The sheath assembly 1624 includes a spool or ring member.This sheath assembly can be used in connection with the cordlessillumination assembly or alternative sheath assembly designs can beused. As shown in FIGS. 7 and 7A, the extending base portion 260 of theillumination assembly 230, on the other hand, can be covered using aflexible sheath member 266 in substantial sealing relation. The sheathmember 266 according to this embodiment need only conform to the baseportion 260 since the remainder of the illumination assembly 230 iscontained within the receiving cavity 217, wherein the sheath can beremoved for disposal using a tab 268 that permits tearing of a disposedfrangible tear strip 270.

As noted, alternative embodiments of cordless (e.g., battery-powered)illumination assemblies are contemplated. Referring to FIGS. 15 and 16,there is shown a vaginal speculum apparatus 378 made in accordance withanother embodiment. According to this embodiment, the disposablespeculum 102 of the apparatus is literally identical in construction tothat depicted according to FIG. 1. For this reason, the same referencenumerals are used with similar parts for the sake of clarity. Thedisposable speculum 102 includes a lower blade member 104 having anintegral handle portion 120 that includes a receiving cavity 133 formedtherein. As previously noted, an illumination housing 144, as shown inFIGS. 1-4, but not shown in FIGS. 15 and 16, such as the 78810 modelilluminator manufactured by Welch Allyn, Inc., can be releasably fittedinto the receiving cavity of the handle portion 120 for coupling to thedistal end of a contained light pipe.

A cordless illumination assembly in accordance with this embodiment canalso be interchangeably attached into the receiving cavity 133 of thehandle portion 120 of the speculum 102 without requiring modification tothe speculum. Put another way, a corded illumination assembly housingand the cordless illumination assembly can be interchangeably fittedinto the receiving cavity 133 defined by the handle portion 120 of thespeculum 102 of FIGS. 15-16 according to this embodiment.

Still referring to FIGS. 15 and 16, the cordless illumination assembly380 according to this embodiment is defined by a housing 384 wherein atleast one extremely compact battery 404 is disposed in a lower orproximal end 388 of the housing. The at least one compact battery 404may be a AAAA rechargeable battery, such as that available from SanyoCorp (AAAA Size 1.2 Volt 300 mAh NiMH rechargeable battery). Othersuitable miniature batteries can also be substituted. A miniature lightsource, in this case, a miniature LED (not shown but similar to thatpreviously described as 232, FIG. 22), such as a Model LXHL-PW01 whiteLED manufactured by Lumileds, Inc. is disposed in a distal end of theilluminator housing 384 adjacent a collecting lens 392. If the at leastone battery 404 is of the NiMH type, a circuit external to the batterymay be needed in order to provide the correct current to the LED 232,FIG. 22. The circuit external to the battery 404 could be a constantcurrent circuit set to deliver the current required by the LED 232, FIG.22, similar to that previously depicted in FIG. 22. The NiMH batterydescribed herein typically operates at 1.2 volts and the LED 232, FIG.22, operates at 3.7 volts. Consequently, if fewer than three (3) NiMHbatteries are used, the circuit to the battery 404 would be a voltagebooster circuit.

The illumination assembly 380 further includes circuitry 400, enablingthe voltage of the at least one contained battery 404 to be raised, ifnecessary, to that required by the LED 232, FIG. 22. Typically and asnoted above, the voltage required to power the LED 232, FIG. 22, isabout 3.7 volts. The LED described herein is rated at 1 Watt, has alight output of at least 20 lumens/watt and has a minimum service lifeof at least 1000 hours. An exemplary circuit for performing thisfunction of permitting batteries to be electrically adapted is morefully described in U.S. Patent Application Publication No. 2004/0183482A1, entitled: ELECTRICAL ADAPTER FOR MEDICAL DIAGNOSTIC INSTRUMENTSUSING LEDS AS ILLUMINATION SOURCES, filed Mar. 20, 2003, the contents ofwhich are herein incorporated by reference. A heat sink 396 provided inthe illumination assembly housing 384 permits the heat generated by theLED 232, FIG. 22, and attendant circuitry 400 to be effectivelydissipated. As noted above, the illumination assembly housing 384 issized, owing to the size of the at least one battery 404 and the LED, tobe fitted within the receiving cavity 133 of the handle portion 120 ofthe speculum 102 without any modification thereto and in which thecomponents are arranged such that the proximal end 388 of the assemblyhousing 384 extends only marginally from the handle portion 120 when theillumination assembly housing 384 is inserted therein. The LED isoptically coupled by means of lenses 392 (shown only in FIG. 16) and262, FIG. 27, relative to the proximal end of a light pipe 254, such aspreviously described, or to an existing light pipe 146, FIG. 2.

The working life of the compact battery 404 described herein isrelatively limited. Preferably, the apparatus is configured such thatthe battery is designed to operate over a life extending at leastequivalent to that of a day of examinations. Referring to FIG. 16, arecharging or docking station 408 is provided, the station beingconnectable to an AC power supply (not shown) and including a number ofreceiving slots that define corresponding charging sockets 412. Each ofthe charging sockets 412 is sized for receiving the proximal end 388 ofthe illumination assembly housing 384. The lower extending or proximalend 388 of the illumination assembly housing 384 includes either sealedcircuitry for charging a sealed inductive charge circuit (not shown) orcontacts that are engaged by a pinned or other suitable connection withthe recharging sockets 412, such as charging contacts 286, FIG. 12.Multiple recharging sockets 412 are provided, thereby permittingmultiple illumination assemblies 380 to be stored and simultaneouslycharged for use in the herein described vaginal speculum apparatus 378.The docking station 408 can further include at least one charge levelindicator to indicate when charging is complete. As previously noted, asimilar docking station can be configured for use with any of thecordless or portable illumination assemblies described herein depending,for example, on the geometry thereof.

In addition and referring to FIG. 17, it will be understood that thecorded illumination assembly 140 of FIG. 1 can also be reconfigured toprovide an alternative LED light source in lieu of an incandescent lamp.According to this embodiment, the overall construction of a cordedilluminator assembly 140A is similar and therefore the same referencenumerals are used where applicable. An LED 232, FIG. 22, such as theModel LXHL-PW01 white LED manufactured by Lumileds, Inc. is disposed ina distal portion 148A of a housing 144A. The LED 232, FIG. 22, includesa domed transparent envelope (not shown) that extends from the distalportion 148A for optically coupling with the proximal end of a lightpipe (not shown in this figure) disposed within the handle of a vaginalspeculum, as previously described. The housing 144A is appropriatelysized to be fitted within the receiving cavity 133, FIG. 1, defined bythe handle portion 120, FIG. 1, of the speculum 102, FIG. 1, in asimilar manner to that of the assembly shown in FIG. 1. The inclusion ofthe LED in lieu of a contained incandescent lamp provides a number ofadvantages; for example, increased working life, less heat generation,improved color rendering and less power consumption. As shown in FIG. 17and similar to FIG. 1, a proximal portion of the illumination assemblyhousing 144A includes a strain relief 152 extending to an electricalcable 156 that further extends to a switch assembly 160. An electricalcable 164 extends from the switch assembly 160 to a pronged plug thatengages a corresponding female plug 172, the latter being tethered by acorresponding cable 174 extending to a power supply 176. The switchassembly 160 is defined by an elastomeric housing, having a depressiblebutton 163 that is used to selectively energize the contained LED 232,FIG. 22, within the distal portion 148A of the illumination assemblyhousing 144A.

In operation, each of the corded or tethered illumination assemblies140, 140A or cordless illumination assembly 380 can be disposedinterchangeably within the receiving cavity 133 of the disposablespeculum 102 and coupled with the proximal end of the light pipe 146wherein illumination is conducted through the light pipe by internalreflection to the distal end 147 towards the target. Though not shown,the housing 384 can be configured with a switch member to enableautomatic energization of the contained light source when the housing isdisposed at least a predetermined distance into the receiving cavity 133through engagement with at least one feature on either the housingand/or the interior of the receiving cavity.

Referring to FIGS. 18-21, there is shown a vaginal speculum apparatus1200 in accordance with another embodiment. The speculum apparatus 1200,like the preceding, includes a disposable speculum 1204 as well as anillumination assembly 1260 that is releasably attached to the speculum.In addition and also like the preceding, the speculum 1204 is configuredto permit interchangeable attachment of either a corded illuminationassembly such as 140, FIG. 1, or a cordless (portable) illuminationassembly 1260. For purposes of this embodiment, only the cordlessillumination assembly 1260 is herein discussed in detail.

The disposable speculum 1204 according to this embodiment is defined byan upper or top blade member 1212, a lower blade member 1214 thatincludes an integral handle portion 1216, and a slide member 1220. Eachof the top blade member 1212 and lower blade member 1214 are similarlyconstructed as that shown in FIGS. 1-4 and are formed from a durableclear plastic material, such as an acrylic or polystyrene, wherein eachblade is defined as a trough-shaped elongate member. The top blademember 1212 further includes a downwardly extending lever portion 1222at the proximal end thereof. The slide member 1220, also made from aplastic material, further includes a forked upper portion or yoke 1226that pivotally receives the lever portion 1222 of the top blade member1212. The handle portion 1216, according to this embodiment and unlikethe proceeding, does not include either a light collecting lens or alight pipe, as previously required. Rather, the upper portion of theinterior of the handle portion 1216 is open.

Distally adjacent and part of the handle portion 1216 and disposedbeneath the lower blade member 1214 and extending essentially verticallytherebeneath, is a substantially cylindrical receptacle 1234 having anopen end 1238 and a defined hollow interior that is sized for retainingthe illumination assembly 1260 of the herein described apparatus 1200,as described in greater detail below. It should be readily understood,however, that other geometries can be substituted. The receptacle 1234includes an upper portion 1242, shown only in FIG. 21, which accordingto this embodiment is opaque or black, and a lower portion 1246 which ismade from a clear material, such as that of the lower blade member, thelower portion including the open end 1238. The receptacle 1234 isattached through an opening formed in the lower blade member 1214through which the upper portion 1242 partially extends therethrough, orotherwise the receptacle can be integrally molded so as to form aportion of the lower blade member. According to another alternativeversion, the handle portion 1216 can be modified (e.g., widened—notshown) in order to accept the illumination assembly 1260.

Referring to FIG. 18, an exploded view is provided of the illuminationassembly 1260. According to this specific embodiment, the illuminationassembly 1260 is defined by a hollow casing or housing 1264 sized toaccommodate a number of components, including a prismatic member 1268that is mounted to an upper portion 1269 thereof. The casing 1264retains a miniature light source, which according to this embodiment isa miniature LED 1272, FIG. 19, such as a Model LXHL-PW01 white LED,manufactured by Lumileds, Inc. Alternatively, the light source can be aminiature incandescent lamp, such as a halogen bulb, an arc lamp, orother form of suitable light source. Still alternatively, different LEDscan be substituted, such as, for example, an array of different coloredLEDs (e.g., blue, green) can be provided in the housing and configuredin order to produce in combination a “red-free” filter.

Referring to FIGS. 18 and 19, the miniature LED 1272 is retained withina cartridge 1276. A rechargeable or other battery 1280 is disposedwithin the casing 1264 beneath the cartridge 1276, wherein a metallicconductive strip member 1284 is placed within the interior of the casingalong the exterior of the battery and the cartridge to complete thecircuit. The battery 1280 is retained by a spring 1288 disposed at thelower or negative end of the battery, the casing having an end cap 1292for releasably retaining the above components. Between the prismaticmember 1268 and the cartridge 1276, a condensing lens 1286 is providedaccording to this embodiment, for collecting and uniformly distributinglight output of the miniature LED 1272 through the prismatic member,which includes a mirrored upper surface such that the light output isdirected between the two blade members 1212, 1214. The lens 1286according to this embodiment is piano-convex.

Details relating to the cartridge 1276 of the illumination assembly 1260are now provided with reference to FIG. 19. The cartridge 1276 includesa cylindrical housing body 1304 which, according to this embodiment, ismade from Radel R, polyphenylsulfone or other suitable polymer.Alternatively, the body 1304 can be fabricated from literally anyelectrical insulating material, wherein the miniature LED 1272 (onlypartially shown in FIG. 19) is disposed at a distal end 1306 adjacent areflector cap portion 1310 that is attached in overlaying relationthereto. A printed circuit board (PCB) 1314 containing suitableelectronics 1318 thereupon used for driving (e.g. powering) theminiature LED 1272 and for enabling the LED to be powered by the batterypower source 1280, FIG. 18. A circuit for this purpose is described incommonly assigned and co-pending U.S. Patent Application Publication No.2004/0183482 A1, previously incorporated by reference in its entirety.The PCB 1314 according to this embodiment, is disposed immediately belowor proximal to the miniature LED 1272, and includes an opening 1322 forreceiving the projecting portion 1326 of a heat sink 1330, retained bythe housing body 1304 in order to dissipate heat that is generated bythe miniature LED 1272, as well as heat also generated by the PCB 1314.

The heat sink 1330 includes an axial groove 1327 extending over theentire axial length thereof and is sized to retain one of a pair ofelectrical contacts. A first electrical contact 1329 extends from theproximal side of the printed circuit board 1314 and includes a lead wireand a strip member 1334. The strip member 1334 of this electricalcontact 1329, when finally assembled, is sandwiched between a cartridgecollar 1333 and the exterior of the cartridge body 1304. A secondelectrical contact 1331 is formed from a lead wire that extends axiallyfrom a battery contact board 1335, the board being retained within thebottom of the cartridge body 1304. According to this embodiment, thefirst electrical contact 1329 is a negative electrical contact while thesecond electrical contact 1331 is a positive electrical contact in whichthe positive terminal of the battery 1280, FIG. 18, is contacted by arivet 1337 that is disposed within a chamfered hole 1339 at the bottomof the cartridge body 1304.

Still referring to FIG. 19, the reflector cap portion 1310 is defined bya through opening 1336 that is fitted about the lens envelope of theminiature LED 1272, the through opening according to one embodimenthaving an inwardly tapered surface 1338 that is used in order toeffectively focus the light emitted from the miniature LED 1272 onto thecondensing lens 1286, FIG. 18, which is fitted between the prismaticmember 1268 and the LED 1272. The reflector cap portion 1310 accordingto this embodiment also recesses the LED lens and protects the lens fromdamage, such as from dropping the cartridge 1276, when removed from theillumination assembly casing 1264 for cleaning.

In passing, it should be noted that the cartridge 1276 is entirelyportable and modular and therefore, for example, other LEDs or lightsources could be substituted in the herein described illuminationassembly by simple substitution of another cartridge having a differentlight source.

Referring to FIGS. 18 and 19, a negative electrical contact is createdas the battery 1280 is pushed axially against the contact spring 1288 bymeans of a rotary switch assembly (not shown). As the switch is engaged,the strip 1334 of the electrical contact 1329 contacts the cartridgecollar 1333 wherein the contact board 1335 within the cartridge body1304 contacts the positive battery terminal, completing the circuit, andenergizing the LED 1272.

It should be noted that other forms of switch assemblies, such asoptical switches, magnetic/reed switches and/or other mechanicalswitches which automatically energize and de-energize the contained LED,and/or other forms of assembly can be utilized. It should be furthernote in passing that each of the preceding handle portions can include afeature, such as a groove or slot, which permits manual engagement by auser of an exterior switch member, such as 248, FIG. 12.

In operation, the illumination assembly 1260 is releasably attached tothe cylindrical receptacle 1234 of the disposable speculum 1204 suchthat the prismatic member 1268 is placed into the upper portion 1242,FIGS. 20, 21, of the receptacle extending into the opening providedbetween the two blade members 1212, 1214, wherein the upper portion ofthe lower blade member 1214 has a distal facing opening (not shown). Inthis orientation, the light emitting surface of the prismatic member1268 is directed axially towards the opening between the top and lowerblade members 1212, 1214. The casing 1264 is accommodated by means of afriction or interference fit with the interior walls of the receptacle1234, although other suitable releasable retention schemes, such assnap-fitting, can be used.

Providing the present illumination assembly 1260 according to thepresent embodiment eliminates the need to mold or otherwise provide alight pipe or a similar light coupling means in the lower blade member1214, such as provided in FIGS. 2-4. In addition, because theillumination assembly 1260 is battery powered, no cabling is required.Therefore, the herein described apparatus becomes more versatile, forexample, permitting use for bed-ridden patients preventing entanglementwith the clinician or patient, and preventing the risk ofcross-contamination due to dirt collecting on cables. As in thepreceding, the batteries are rechargeable and the illumination assemblycan be placed within a docking station, such as depicted in FIG. 16, toenable recharging.

Another vaginal speculum apparatus 300 made in accordance with thepresent application is depicted in FIGS. 28-31. As in the preceding, theapparatus 300 includes a disposable speculum 304 and an illuminationassembly 306 that is releasably attached to the speculum, theillumination assembly having a contained light source (not shown).

The disposable speculum 304 shown herein is similar to that described inFIGS. 1-4 in that the speculum includes an upper or top blade member 308and a lower or bottom blade member 312, the latter including an integralhandle portion 316 having a bottom end opening extending into areceiving cavity 317. A slide member 320 is attached to the rear side ofthe speculum 304, the slide member being fitted into a slot formed onthe rear facing side of the handle portion 316 and including a yoke 332at an upper end thereof that permits the pivotable attachment of theupper blade member 308 thereto. The upper blade member 308 furtherincludes a lever portion 324 that extends downwardly from the proximalend of the upper blade member, the lever portion having an opening 336defining an aperture that permits a user to view between the upper andlower blade members 308, 312 through the yoke 332 of the slide member320. The bottom of the lever portion 324 includes a tab 340 having aninterior slot 344 that engages with a curved member 348 rearwardlyextending from the slide member 320, the rearwardly extending memberbeing flexible and having a set of ratchet teeth 352 along a bottomsurface thereof, permitting the selective articulation of the upperblade member 308 relative to the lower blade member 312.

The slide member 320 further includes a lower tongue 356 having a singletooth at its bottom end that engages with a set of ratchet teeth 358provided on the rear facing side proximate the bottom of the handleportion 316. The tongue 356 can be retroflexed to release the tooth fromthe set of teeth 358 in order to permit vertical adjustment of the upperblade member 308 relative to the lower blade member 312. Further detailsconcerning the design and the articulation of the disposable speculum304 are provided in U.S. Pat. No. 3,716,047, previously incorporatedherein by reference in its entirety.

With this background, discussion is now made of the illuminationassembly 306 in accordance with this particular embodiment. Stillreferring to FIGS. 28-31, the illumination assembly 306 includes anillumination source housing 360 that is disposed in side-by-siderelation with a battery housing 364, each of the housings beingsupported by a base section 372. The illumination source housing 360 issized to be fitted within the receiving cavity 317 of the handle portion316 of the disposable speculum 304 while the battery housing 364 iscontoured to be fitted in adjacent relation relative to the exterior ofthe handle portion 316, the battery housing assuming a parallelorientation thereto. As shown in FIGS. 30 and 31, the battery housing364 can be provided either in front of or behind the handle portion 316in terms of positioning.

The battery housing 364 is sized to retain at least one lithium ion orother form of battery (not shown), enabling the illumination assembly306 to be used without tethering or connection to an exterior (e.g., AC)power supply. A rotatable switch 368 is located at the top of thebattery housing 364, the switch being electrically connected to thecontacts of the battery and the contained light source to enableenergization of the contained light source (e.g., a white LED) withinthe illumination source housing 360. Electrical connection is effectedby a metal tube that moves vertically when the switch 368 is rotated,the vertical motion causing the tube to touch a metal contact inside thehousing 364. Alternatively, other switches can be used with thisembodiment of the illumination assembly 360. For example, a switch ofthe type shown in FIGS. 11 and 12 can be used, that switch having theadvantage of being enabled automatically (by sliding downward) when theillumination assembly 306 is inserted into the receiving cavity 317 ofthe handle portion 316 and disabled automatically (by sliding upward tothe original position under the action of a spring internal to thehousing 364) when removed from the receiving cavity 317.

The light source is preferably disposed in relation to the distal end ofthe illumination source housing 360, according to this embodiment,enabling the light source to be coupled with the light pipe 254, FIG.27, at the distal end of the receiving cavity 317 of the handle portion316 in the same manner as previously described, the light pipepreferably having a scalloped, curved or otherwise contoured distallight-emitting end 258, as previously described and shown in FIGS.25-27.

Alternatively, other exemplary embodiments of portable illuminationassemblies for use with a disposable speculum are shown in FIGS. 35-39.Referring to FIG. 35, a vaginal speculum apparatus 500 includes anillumination assembly 504 comprising a compact housing 508 that can bedisposed within the top blade 512 of a vaginal speculum 510 such that acontained white or other color LED or other miniature contained lightsource (not shown) is aligned along the longitudinal axis of the topblade. The speculum 510 is similar to those previously describedincluding the top blade 512 and a lower blade 516 having a downwardlydepending handle portion 520. An articulation mechanism 524 is alsoprovided as previously described in which a lever portion 528 extendingfrom a proximal end 530 of the top blade 512 is engageable with teethprovided on a flexible projection 532 extending outwardly from the lowerportion of a yoke 534 of a slide member 538. A lower tongue 542 enablesadjustable movement of the slide member 538 along the exterior of thehandle portion 520 in which relative movement can be provided betweenthe blades 512, 516 to dilate a patient. The housing 508, which can bereusable or expendable according to this embodiment, further contains atleast one battery and resident circuitry for powering the LED. Thehousing 508 is releasably attached to the top blade 512 according tothis embodiment although the housing can be alternatively positionedrelative to either the top blade or the lower blade 516 of the speculum510, as discussed herein. Clips, fasteners or other conventional meanscan be used to releasably attach the housing 508 to the blade 512,wherein the illumination assembly 504 can also be used separately as anexamination light when detached. At least one optical element 526, suchas a focusing lens, may be disposed in front of the contained LED,either within the housing 508 or otherwise within the blade 512, fordistributing the emitted light. In addition, a clear, thin plasticsheath (not shown) can be disposed about the assembly prior toexamination in order to prevent contamination in the event the portableillumination assembly 504 is intended for reuse.

Referring to FIGS. 36 and 37 and according to another embodiment made inaccordance with the present invention, a vaginal speculum apparatus 600can be provided that includes an illuminator assembly 604 that can bereleasably attached to the top blade 612 of a disposable speculum 610.The disposable speculum 610 is similarly designed in accordance to theprior embodiments discussed herein and including the top blade 612, aswell as a lower blade 614, a slide member 616 and a hollow handle 618.As described in prior embodiments, the slide member 616 is part of anarticulation mechanism including a yoke or upper section 620 thatextends upwardly and permits pivotal connection of the top blade 612 bymeans of a lever portion 624 downwardly extending from a proximal end625 of the blade. The top and lower blades 612, 614 define a proximalviewing aperture 630 therebetween for the user, as previously discussed.

In this particular embodiment, the portable illumination assembly 604 isattached to a top surface 634 at the proximal (rearward) end of the topblade 612. The assembly 604 is defined by a compact housing 640 sized toretain a miniature light source, such as at least one LED, as well asbatteries separately provided in spaced depending leg portions 644, 648of the housing. It should be readily apparent that the number andorientation of the batteries can be varied, for example, depending onsizing of the batteries themselves and should not be limited by thisexemplary configuration. In addition, the batteries can be rechargeable,the housing according to one version including an inductive loop orsimilar recharging circuit, permitting the housing 640 to behermetically sealed. Otherwise, the batteries can be releasably attachedwithin the housing. The housing 640 further includes a prismatic member642, which is optically coupled by means of at least one lens element(not shown in this view) to the contained light source (LED(s)). Thehousing 640, according to this embodiment, is substantially U-shaped,including the leg portions 644, 648 and a connective base portion 652but it will be readily apparent that numerous other designconfigurations are possible. The base portion 652 is secured to the topblade 612 by conventional means, such as by at least one fastener. Thebase portion 652 further includes a proximal extending section 656 thatretains the prismatic member 642, the proximal portion extendingdownwardly over the rear edge of the blade 612 wherein the prismaticmember is aligned with the opening formed in the lever portion 624 suchthat the light emitting surface of the prismatic member is aligned withthe viewing opening 430 between the top and lower blades 612, 614.

The contained LED is electrically connected to the batteries and to theresident circuitry to enable energization of the LED or other containedlight source. A switch assembly (not shown) permits selective poweringof the contained light source.

Still other alternative embodiments are possible. Referring to FIG. 23,a vaginal speculum apparatus 700 includes a self-contained portableillumination assembly 704 which is releasably attached in conjunctionwith the lower blade 712 of a disposable speculum 710. As in precedingembodiments, the speculum 710 is defined by a top blade 711 and thelower blade 712, the latter including a hollow handle portion 716. Anarticulation mechanism 724 includes a lever portion 728 extendingdownwardly from a proximal end 730 of the top blade 711 that isengageable with teeth provided on a flexible projection 732 extendingoutwardly from the lower end of a yoke 736 of a slide member 740. Aflexible tongue 744 enables movement of the slide member 740 to permitthe top and lower blades 711, 712 and enable dilation of a patient.

In this embodiment, the portable illumination assembly 704 comprises acompact housing 750 that retains a miniature light source 754, such asat least one white or other color LED, as previously described, as wellas a portable power supply and resident circuitry for powering thecontained LED. According to this design, the output of the containedlight source 754 is optically and structurally coupled to a lightcollecting lens 758 formed or connected at a proximal end 760 of a lightpipe 764, the latter extending within a trough-shaped portion of thelower blade 712. Because the illumination assembly 704 is cordless,according to this and the prior described embodiments, the apparatus 700is quite versatile and can be used, for example, with bed-riddenpatients. As such, there are no issues such as previously encounteredwith cabled assemblies. The illumination assembly 704 can be easilyreused by removing same from the speculum 710 after examination anddiscarding the speculum. Alternatively, the speculum 710 andillumination assembly 704 can each be discarded following single orsingle patient use. In instances in which reusable use is intended, theillumination assembly 704 can be covered prior to use with a disposablesheath 766. An exemplary version of such a sheath is described in U.S.Ser. No. 10/393,848, the entire contents of which are hereinincorporated by reference.

Yet another embodiment of a vaginal speculum apparatus 800 is shown inFIG. 24. This apparatus 800 includes a portable illumination assembly804 that is releasably or otherwise engaged with a vaginal speculum 810.As in preceding embodiments, the speculum 810 is defined by a top blade811 and the lower blade 812, the latter including a downwardly extendingand hollow handle portion 816. An articulation mechanism 824 includes alever portion 828 extending downwardly from a proximal end 830 of thetop blade 811 that is engageable with teeth provided on a flexibleprojection 832 extending outwardly from the lower end of a yoke 836 of aslide member 840. A flexible tongue 844 enables movement of the slidemember 840 to permit the top and lower blades 811, 812 to permit patientdilation. The yoke member 836 and the lever portion 828 combine to forma viewing aperture at the rear of the speculum 810.

The illumination assembly 808 is defined by a compact housing 850 thatis sized to be fitted into an open slot or cavity 815 of the hollowhandle 816 or otherwise attached to the lower blade. The housing 850retains a portable power supply (not shown), such as at least onebattery, and resident circuitry (not shown) for powering a containedlight source 854, such as a white LED. According to this embodiment, thelight source 854 is disposed above the hollow handle portion 816 andmore specifically at the proximal end of the trough-shaped lower blade812 along a surface thereof, and in the position of the light emittingend of the light pipe of the prior embodiments. The light source 854 iscoupled to the remainder of the housing 850 by a set of lead wires andelectrical contacts 860, the latter being covered by an assemblyenclosure 864 which is fluid-sealed. In one version, the enclosure 864is formed, by a wall or barrier 868 forming a suitable compartment orcan otherwise be alternatively provided as part of the housing itself aspreviously described in related embodiments.

PARTS LIST FOR FIGS. 1-37

-   100 vaginal speculum apparatus-   102 disposable speculum-   102 disposable speculum-   104 lower or bottom blade member-   108 upper or top blade member-   112 slide member-   116 trough-shaped distal blade-   120 handle portion-   123 rear flexible projection-   124 forked upper end or yoke-   125 ratchet teeth-   128 lever portion-   129 tongue-   130 ratchet tooth-   131 teeth-   133 receiving cavity-   134 slot-   135 viewing aperture-   136 lateral spring-like protrusions-   137 tab-   139 interior slot-   140 illumination assembly, corded-   140A illumination assembly, corded-   140B illumination assembly, corded-   144 housing, illumination assembly-   144A housing, illumination assembly-   144B housing, illumination assembly-   146 light pipe-   147 distal light-emitting end-   148 distal portion-   148A distal portion-   148B distal portion-   152 strain relief-   156 electrical cable-   160 switch assembly-   163 depressible button-   164 electrical cable-   168 pronged plug-   172 female plug-   174 cable-   176 power supply transformer-   200 vaginal speculum apparatus-   204 disposable speculum-   212 upper or top blade member-   214 lower or bottom blade member-   215 elongate section or blade-   216 handle portion-   216A handle portion-   217 receiving cavity-   217A receiving cavity-   220 slide member-   221 opening-   222 external teeth-   223 guide slot-   224 lever portion-   225 flexible projection-   226 ratchet teeth-   227 bottom tab-   228 yoke or upper portion-   229 lower tongue-   230 illumination assembly-   232 LED-   235 top surface-   236 housing-   238 tubular open-ended extending portion-   240 circuit board-   241 spacer tube-   242 battery-   243 conductive contacts-   244 heat sink-   245 upper portion-   246 internal centering fingers-   247 short circuit/over circuit protection device-   248 slider switch-   249 guide rails-   250 rail like portions-   250A rails-   251 LED driver-   253 projections-   254 light pipe-   255 proximal end-   256 ribs, vertically extending-   258 distal end-   259 lens-   260 base portion-   261 pin, detent-   262 collecting lens-   263 leaf spring-   264 pedestal section-   265 annular gap-   266 sheath member-   268 tab-   270 frangible tear strip-   272 recessed portion-   276 inner walled cavity-   280 tabs-   281 speculum adapter-   282 external envelope-   283 internal envelope-   284 plunger, spring loaded-   285 guide rails-   286 charging contacts-   287 bottom surface-   288 power adapter-   289 clamping recess-   290 conductive strip member-   291 plug-in cord-   292 lower end-   293 cable-   294 switch contacts-   295 low-power indicator-   296 transformer-   297 receptacle-   298 power adapter-   299 pins-   300 vaginal speculum apparatus-   304 disposable speculum-   306 illumination assembly-   308 upper or top blade member-   312 lower or bottom blade member-   316 handle portion-   317 receiving cavity-   320 slide member-   324 lever potion-   332 yoke-   336 opening-   340 tab-   344 interior slot-   348 curved member-   352 ratchet teeth-   356 tongue-   358 teeth, ratchet-   360 illumination source housing-   364 battery housing-   368 rotatable switch-   372 base section-   378 apparatus-   380 illumination assembly-   384 housing-   388 lower or proximal end-   392 lens-   396 heat sink-   400 circuitry-   404 battery-   408 docking station-   412 charging sockets-   500 vaginal speculum apparatus-   504 illumination assembly-   508 compact housing-   510 speculum-   512 top blade, speculum-   516 lower blade, speculum-   520 handle portion, lower blade-   524 articulation mechanism-   526 optical element-   528 lever portion-   530 proximal end, top blade-   532 flexible projection-   534 yoke or upper section-   538 slide member-   542 flexible tongue-   600 vaginal speculum apparatus-   604 illumination assembly-   610 disposable speculum-   612 top blade, speculum-   614 lower blade, speculum-   616 slide member-   618 hollow handle-   620 yoke or upper section-   625 proximal portion, blade-   630 viewing aperture-   634 top surface-   640 housing-   642 prismatic member-   644 leg portion-   648 leg portion-   652 base portion-   656 proximal extending portion-   700 vaginal speculum apparatus-   704 illumination assembly-   710 disposable speculum-   711 top blade, speculum-   712 lower blade, speculum-   716 handle portion-   724 articulation mechanism-   728 lever portion-   730 proximal end, top blade-   732 flexible projection-   736 yoke-   740 slide member-   744 flexible tongue-   750 housing-   754 light source-   758 lens-   760 proximal end, light pipe-   764 light pipe-   766 disposable sheath-   800 vaginal speculum apparatus-   804 illumination assembly-   810 vaginal speculum-   811 top blade, speculum-   812 lower blade, speculum-   815 open slot or cavity-   816 handle portion-   824 articulation mechanism-   828 lever portion-   830 proximal end, top blade-   832 flexible projection-   836 yoke-   840 slide member-   844 flexible tongue-   850 housing-   854 light source-   860 lead wires and electrical contacts-   864 enclosure-   868 wall or barrier-   1200 vaginal speculum apparatus-   1204 disposable speculum-   1212 upper or top blade member-   1214 lower blade member-   1216 integral handle portion-   1220 slide member-   1222 lever portion-   1226 yoke or upper portion-   1234 receptacle-   1238 open end-   1242 upper portion-   1246 lower portion-   1260 illumination assembly-   1264 casing or housing, hollow-   1268 prismatic member-   1269 upper portion-   1272 miniature LED-   1276 cartridge-   1280 battery-   1284 electrically conductive strip member-   1286 condensing lens-   1288 spring-   1292 end cap-   1304 housing, cartridge-   1306 distal end-   1310 reflector cap portion-   1314 circuit board-   1318 circuitry-   1322 opening-   1326 projecting end-   1327 axial groove-   1329 electrical contact-   1330 heat sink-   1331 electrical contact-   1333 cartridge collar-   1334 strip member-   1335 battery contact board-   1336 opening-   1337 rivet-   1338 tapered portion-   1339 chamfered hole-   1600 vaginal speculum apparatus-   1608 illumination assembly-   1612 housing-   1614 light source-   1616 light collecting lens-   1620 light pipe-   1624 disposable sheath assembly-   1628 spool member-   1632 sheath-   1700 vaginal speculum apparatus-   1708 illumination assembly-   1712 housing-   1716 light source-   1720 lead wires-   1724 enclosure-   1725 barrier/wall

It should be readily apparent that other variations and modificationswill be possible to those of sufficient skill in the field, thesevariations and modifications being considered within the inventiveambits described herein. For example, though each of the precedingembodiments depict a specific battery relation, other configurations andorientations capable of electrical interconnection can be used withinthe intended scope and breadth according to the following claims. Inaddition and though each of the embodiments related directly to aspeculum with an enclosed receiving cavity, it is conceivable that theembodiments described herein can also be used, for example, withspeculums having open-walled handle portions. Still further, theillumination assembly discussed with regard to each of the embodimentscan be either a disposable version or, as described by a number ofembodiments herein, a reusable assembly that can be attached to adisposable speculum.

We claim:
 1. A vaginal speculum apparatus comprising: a vaginal speculumcomprising: an upper blade, a lower blade, and a mechanism for causingrelative movement between the upper and lower blade in order to dilatethe cervix of a female patient, said lower blade further including ahandle having an elongated receiving cavity with an open lower end; andan illuminator comprising an illuminator housing that retains a lightsource and at least one battery, in which the illuminator housing has anupper portion and a lower base portion wherein only the upper portion ofthe illumination housing can be fitted in the receiving cavity of thehandle.
 2. The speculum apparatus according to claim 1, in which theilluminator includes a feature on the housing for selectively energizingthe light source.
 3. The speculum apparatus according to claim 2, inwhich the contained light source is automatically energized when theupper portion of the illuminator housing is positioned within thereceiving cavity of the handle.
 4. The speculum apparatus according toclaim 3, in which the feature automatically energizes the containedlight source when the illuminator housing is positioned a predetermineddistance within the receiving cavity of the handle.
 5. The speculumapparatus according to claim 1, wherein the lower base portion of theillumination housing is wider than the receiving cavity of the handle.6. The speculum apparatus according to claim 1, wherein the receivingcavity of the handle is defined by a closed upper end opposite the openlower end, the speculum further comprising a curved light pipe having aproximal end that is adjacent the closed upper end of the receivingcavity.
 7. The speculum apparatus according to claim 6, wherein thecurved light pipe has a distal end that extends along the lower blade.8. The speculum apparatus according to claim 7, wherein the upperportion of the illuminator housing includes a light emitting end that isoptically coupled to the proximal end of the curved light pipe when theilluminator housing is inserted the predetermined distance into thereceiving cavity.
 9. The speculum apparatus according to claim 1,wherein the handle includes a plurality of heat dissipating ribs on theexterior of the handle.
 10. The speculum apparatus according to claim 1,further including an articulation mechanism for moving the upper bladerelative to the lower blade.
 11. The speculum apparatus according toclaim 10, wherein the articulation mechanism includes a yoke provided ona proximal end of the lower blade that engages a lever portion extendingfrom a proximal end of the upper blade.
 12. The speculum apparatusaccording to claim 1, wherein the speculum is made from an opticallyclear plastic.
 13. The speculum apparatus according to claim 1, in whichthe illuminator is releasably attachable to the receiving cavity of thehandle.
 14. The speculum apparatus according to claim 2, in which thefeature for selectively energizing the light source is a switch that isengaged when the illuminator housing is positioned in the receivingcavity of the handle.
 15. The speculum apparatus according to claim 14,in which the switch is located on the upper portion of the illuminatorhousing.
 16. A vaginal speculum assembly comprising: a vaginal speculumcomprising: an upper blade, a lower blade, and a handle, the handlehaving a retaining cavity which includes an open lower end; and anilluminator disposed in the retaining cavity of the handle, theilluminator including a light source, at least one battery for poweringthe light source, and an accessible feature for energizing the lightsource that can be accessed when the illuminator is positioned withinthe receiving cavity of the handle.
 17. The speculum assembly accordingto claim 16, including a curved light pipe having a proximal end that isoptically coupled to the light source for directing light to a medicaltarget.
 18. The speculum assembly according to claim 16, furthercomprising a mechanism for selectively adjusting a spacing between theupper and lower blades.
 19. The speculum assembly according to claim 17,in which an upper end of the receiving cavity is adjacent the proximalend of the curved light pipe.
 20. A vaginal speculum apparatuscomprising: a vaginal speculum comprising: an upper blade, a lowerblade, and an articulation mechanism for adjusting the spacing betweenthe upper and lower blades; and an illuminator attached to the speculumat a proximal end of the upper blade, the illuminator including ahousing retaining a light source and at least one battery, wherein theilluminator is releasably attachable to the speculum.